1. Field of the Invention
The present invention relates to an automated test apparatus for risk and integrity testing for pharmaceutical filtration membranes and method thereof, in particular relates to the risk and integrity testing for pharmaceutical filtration membranes for preparation of aseptic pharmaceutical production, and its isolated apparatuses.
2. Description of Related Art
Conventional methods of medicinal liquid filtration use a filter to exert pressure followed by a 0.2 μm membrane for filtration. The membrane needs to undergo an integrity test before and after the filtration to ensure the complete blocking of microorganisms in the medicinal liquid as a quality control standard before releasing the products. The European GMP (PIC/S GMP Annex 1, Article 113) requests that membranes used as a filter for aseptic medicine preparation should be sterilized and tested for its integrity before use, and should also be verified after use with an appropriate test method (for example, blistering testing, diffusion flow, or holding pressure testing).
Although a confirmation of membrane integrity prior to use may reduce filtrate waste. Nevertheless, the approach of filtration test (Pre-Use Post Sterilization Integrity Test, PUPSIT) is still controversial, and a test operation in any form may increase the risk of contamination to the membrane, and the use of pre-test of integrity is to enhance the chance of contamination to the membrane. Moreover, if it is really damaged the membrane, the integrity test after use can be performed and detected, it is unnecessarily that the integrity testing has to be done prior to use. The only consensus reached is to adopt a risk assessment approach to determine whether to perform PUPSIT.
Although the confirmation of membrane integrity before use may reduce filtrate waste, one of disadvantages of the conventional approach is that any operation for the membrane integrity testing is likely to increase the risk of contamination, and the integrity test before use is one that increased probability of membrane contamination.
Another drawback of the conventional approach is that after completion of radiopharmaceuticals labeling, the present filter integrity testing begins with manual operation, that not only has the problem of radioactive exposure, there are test reproducibility and accuracy of the process need to be improved. If the drawback in these issues receives no proper treatment, it may result in excessive exposure and test result accuracy shortcomings to occur.
U.S. Pat. No. 7,770,434 disclosed a method of medicine dispensing in-process integrity testing without dismantling filter membranes. However, it did not disclose a computer controlled automated integrity and risk testing for filter membrane, respectively, after and before filtration, and the outputs of filter membrane were not concurrently connected to bubble generating bottles and pharmaceutical product bottles, respectively.
In view of the above described drawbacks arising after the completion of radiopharmaceutical labeling during filter membranes integrity testing before and after filtering process, the inventors of the present invention are aiming for solving drawbacks in a way of continuous study and research and eventually this invention is presented.